The following data is part of a premarket notification filed by Hewlett-packard Co. with the FDA for Ultrasound 77030 Imaging System.
Device ID | K944048 |
510k Number | K944048 |
Device Name: | ULTRASOUND 77030 IMAGING SYSTEM |
Classification | System, Imaging, Pulsed Doppler, Ultrasonic |
Applicant | HEWLETT-PACKARD CO. 3000 MINUTEMAN RD. Andover, MA 01810 -1099 |
Contact | Paul Schrader |
Correspondent | Paul Schrader HEWLETT-PACKARD CO. 3000 MINUTEMAN RD. Andover, MA 01810 -1099 |
Product Code | IYN |
CFR Regulation Number | 892.1550 [🔎] |
Decision | Substantially Equivalent (SESE) |
Type | Traditional |
3rd Party Reviewed | No |
Combination Product | No |
Date Received | 1994-08-18 |
Decision Date | 1995-03-01 |